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    CE Marking Specialists


    A South Wales based Product  Certification and training company, specialising in supporting small to medium enterprises in meeting their CE Marking obligations


  • Specialists in EMC and Low Voltage

    (Safety) Directives


    We specialise in European and Worldwide approvals.

  • Flexible, Professional, and Affordable Service


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Category: News

Gainspeed Newsletter 2019 issue 5

More useful information on upcoming standards!

Headlines

Standards Watch
European standards being withdrawn
Other standards being withdrawn
Lists of European Harmonised Standards
Update on Harmonised Standards Lists
Accreditation and Market Surveillance (765/2008)
Refresher
An ISO Guide to Quality Management Principles
New / updated Standards – details of changes
ISO 44002:2019
IEC 61326-1: 2019 (CDV)
CE Marking – Traceability Requirements
EMC ADCO Common Statement
New Standards Published
August 2019
September 2019
October 2019
Compliance Calendar

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2019-11-20 15:56:24

FCC Labeling for Unintentional Radiators

Labeling for FCC can be confusing with new changes for SDOC and Certification procedures. We hope this step by step guide makes the whole process simpler for our visitors and customers.


Step 1:

 Is the product already on the market with correct and suitable support documentation and has not been modified since this documentation was created?

  1. YES: FCC Documentation does not need updating to new SDoC procedure until the unit is modified again. Guidance on updating No further action required.
  2. NO: EUT is new or is modified since last documentation issued. Continue to step 2.

Step 2:

Choose correct method for submitting an unintentional radiator, either;

  1. SDoC
  2. Certification

Equipment authorization guide


Step 3:

If method chosen is SDoC continue to “SDoC Process”.

If method is certification go to “Certification Process”.



SDoC Process

Step 1, USA Representative Requirements:

United States representative must be assigned, they must be:

  • Located in the United States
  • Be either Manufacturer, assembler or importer
  • Assume all liabilities for guaranteeing compliance of the equipment
  • Compliance information provided with equipment must have their name, US address and telephone or internet contact information
  • Able to produce compliance information on request without cost to the FCC
  • SDoC must match the build level of the unit with the SDoC with only variation expected due to quantity production and testing on a statistical basis

More Information


Step 2, Testing:

Testing for FCC must be carried out by a reputable laboratory, which does not need to be necessarily an accredited testing laboratory. Unless the product is one of the following..

  • Scanning receivers, Radar Detectors and access broad band over power line equipment.

A laboratory that makes measurements of equipment subject to an equipment authorization under the certification procedure or Supplier’s Declaration of Conformity shall compile a description of the measurement facilities employed if not already accredited.

(1) The description of the measurement facilities shall contain the following information:

(i) Location of the test site.

(ii) Physical description of the test site accompanied by photographs that clearly show the details of the test site.

(iii) A drawing showing the dimensions of the site, physical layout of all supporting structures, and all structures within 5 times the distance between the measuring antenna and the device being measured.

(iv) Description of structures used to support the device being measured and the test instrumentation.

(v) List of measuring equipment used.

(vi) Information concerning the calibration of the measuring equipment, i.e., the date the equipment was last calibrated and how often the equipment is calibrated.

(vii) For a measurement facility that will be used for testing radiated emissions, a plot of site attenuation data taken pursuant to paragraph (d) of this section.

Source


Step 3, Test Reports:

Test reports must be signed by a representative of the responsible party with the authority to act on behalf of the responsible party. It is not necessary for the representative that signs the test report to be located in the United States.


Step 4: Trade name, Model number, and unique identifier (Serial No.)

FCC requires that each device be uniquely identified (for example, using a label listing   trade name and type or model number) This is described as a label but should be permanently affixed to the product unless, size or manufacture makes this impractical due to eligibility.

Small or impracticable labelling requirements A.2


Step 5, Compliance Statement:

A compliance statement should be labelled on the product unless the unit is so small or it is impracticable. E-labelling may also be used.

Small or impracticable labelling requirements A.2

E-Labelling

The following statements should be chosen respectively:

(1) Receivers associated with licensed radio service operations:

This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference.

(2) Stand-alone cable input selector switch:

This device complies with part 15 of the FCC Rules for use with cable television service.

(3) All other devices:

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.


Step 6: Compliance information statement

    This must be supplied with the product at the time of marketing or importation. This      can be in the manual, product insert, computer disk, web page or devices own         electronic screen. The information must be reasonably accessible to the end user.

This should contain.

  • Model and trade name. (example Apple, IPhone X)
  • Name, address, telephone or internet contact information of the responsible party
  • Statement that the product complies with the rules
  • Copies of the compliance information statements for each authorized component used in the system that is authorized under SDoC.
  • Identification of the authorized components used in the assembly.

Example

Source (Appendix A)


Step 7: part 15 information to be provided to the user.

For devices approved under Part 15, the user’s manual or instruction manual for an intentional or unintentional radiator shall caution the user about changes or modifications to the device.

For Class A and Class B digital devices, information to the user is required to include the following statements:

For a Class A digital device or peripheral, the instructions furnished to the user shall include the following or similar statement, placed in a prominent location in the text of the manual:

NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.

For a Class B digital device or peripheral, the instructions furnished to the user shall include the following or similar statement, placed in a prominent location in the text of the manual:

NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

—Reorient or relocate the receiving antenna.

—Increase the separation between the equipment and receiver.

—Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

—Consult the dealer or an experienced radio/TV technician for help.

Source


Step 8, FCC Logo:

Devices authorized under the SDoC procedure have the option to use the FCC logo to indicate compliance with the FCC rules, and the logo may be included in the instruction materials or as part of an e-label.

The FCC logo shall only be used on a product that has been tested, evaluated, and found to be compliant in accordance with the SDoC procedures.  The use of the FCC logo on the device does not mitigate the requirement to provide a means to uniquely identify the product or to provide the required compliance information statement.  The FCC logo cannot be used on products that are exempt from an authorization by rule (e.g., Section 15.103 exempt devices, or Section 15.3 incidental radiators) unless the SDoC procedure has been fully applied for the product.

Source


Step 9, RF Exposure:

In many instances it may be necessary to provide additional information to the user for RF exposure compliance., Such RF exposure user information must be provided either with instructions manual on how the device accessories must be used for RF exposure compliance, or at minimum, instructions on how to reasonably obtain these instructions. RF exposure labelling and notification requirements are specified in Sections 2.1091 and 2.1093.23 Further guidance for equipment used in general-population/uncontrolled or occupational/controlled environments is provided in various KDB Publications. RF exposure compliance user information may be displayed using the e-labels.

447498 D01 General RF Exposure Guidance v06
447498 D02 SAR Procedures for Dongle Xmtr v02r01
447498 D03 Supplement C Cross-Reference v01



Certification Process

Step 1, Labelling:

For certification, the product shall bear a nameplate or label with the FCC Identifier (FCC ID). The FCC ID must always be accessible when using the product. The placement of the FCC ID must be a physical label on the product, unless an e-label is used.

Physical FCC ID labels must be located on the surface of the product, or within a user-accessible non-detachable compartment (such as the battery compartment). The label shall be permanently affixed, permitting the device to be positively identified. The font needs to be readily legible, consistent with the dimensions of the equipment and its label area.

When the device is so small, or for such use that it is impracticable to label with a font size that is four-points or larger (and the device does not utilize electronic labelling), then the FCC ID shall be placed in the user manual, and the FCC ID shall also be placed either on the device packaging or on a removable label attached to the device. E-Labelling may also be used.


Step 2, packaging information:

Some RF devices are also required to have information included in the packaging of the device (source Appendix A):

E-Label Devices displaying their FCC ID, warning statements, or other information electronically must also be labelled, either on the device or its packaging, with the FCC ID and other information (such as a model number) that permits the devices to be identified at the time of importation, marketing, and sales as complying with the FCC’s equipment authorization requirements. This requirement is in addition to the electronic labelling of the device. Devices can be labelled with a stick-on label, printing on the packaging, a label on a protective bag, or by similar means. Any removable label shall be of a type intended to survive normal shipping and handling and must only be removed by the customer after purchase.

Signal boosters: The advisories shall be provided in on-line, point of sale marketing materials, in print or on-line owner’s manual and installation instructions, on the outside packaging of the device, and on a label affixed to the device.


Step 3, part 15 information to the user:

For devices approved under Part 15, the user’s manual or instruction manual for an intentional or unintentional radiator shall caution the user about changes or modifications to the device.

For Class A and Class B digital devices, information to the user is required to include the following statements:

For a Class A digital device or peripheral, the instructions furnished to the user shall include the following or similar statement, placed in a prominent location in the text of the manual:

NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.

For a Class B digital device or peripheral, the instructions furnished to the user shall include the following or similar statement, placed in a prominent location in the text of the manual:

NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

—Reorient or relocate the receiving antenna.

—Increase the separation between the equipment and receiver.

—Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

—Consult the dealer or an experienced radio/TV technician for help.

Source


Step 4, RF Exposure:

In many instances it may be necessary to provide additional information to the user for RF exposure compliance., Such RF exposure user information must be provided either with instructions manual on how the device accessories must be used for RF exposure compliance, or at minimum, instructions on how to reasonably obtain these instructions. RF exposure labelling and notification requirements are specified in Sections 2.1091 and 2.1093.23 Further guidance for equipment used in general-population/uncontrolled or occupational/controlled environments is provided in various KDB Publications. RF exposure compliance user information may be displayed using the e-labels.

447498 D01 General RF Exposure Guidance v06
447498 D02 SAR Procedures for Dongle Xmtr v02r01
447498 D03 Supplement C Cross-Reference v01

Disclaimer:

This document is provided for information purposes only and does not replace the need to obtain further independent advice and/or to instruct/appoint a notified or competent body or person(s) to carry out further investigation and/or testing. National and International Regulations are constantly changing and evolving. Accordingly, no warranty is given, nor is any term or condition to be implied, that the information provided in this document is accurate and that it eliminates the need for seeking further advice or investigation.

November 2019

 

Posted in News, Uncategorized |

Gainspeed Newsletter 2020 Issue 6

Happy New Year and thank you for subscribing to our newsletter!

This year looks to be very interesting with some major reforms across the board.  So let us do the work and keep you up to date on all the upcoming  changes for 2020.

Headlines
Standards Watch
European standards being withdrawn
Lists of European Harmonised Standards
Update on Harmonised Standards Lists
Low Voltage Directive (2014/35/EU)
New / updated Standards – details of changes
BS EN ISO 20607:2019
Sustainability
SCIP Database
ECHA Newsletters
New Standards Published
October 2019
November 2019
December 2019
Compliance Calendar

Download

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2020-01-02 12:26:16
Posted in News, News Letter |

Gainspeed Newsletter 2020 Issue 1

Thank you for subscribing to our newsletter!

This month we look at the new standards for Sustainability and Eco Design.

Headlines
Standards Watch
European standards being withdrawn
Lists of European Harmonised Standards
Update on Harmonised Standards Lists
Radio Equipment Directive (2014/53/EU)
Sustainability
BS EN IEC 62430:2019
BS EN ISO 14006:2020
ECHA Newsletters
New Standards Published
January 2020
February 2020
Compliance Calendar

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View Online

2020-03-24 09:44:11
Posted in News, News Letter |

MDR (Medical Devices Regulation) to be delayed for one year

European Commission has posted the following on the MDR application date:

With patient health and safety as a guiding principle, the Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May. This will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.

This will surely be a relief to many manufacturers currently under pressure to meet the new requirements in light of the COVID-19 crisis.

For more information see below.

https://ec.europa.eu/growth/sectors/medical-devices/new-regulations_en